Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation

NCT02812290 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Alberta

Phase

Observational

Started

2016-05

Last updated

2026-05-28

Condition(s) studied

Lung Transplant Rejection

Investigational drug(s) / intervention(s)

Lung transplant biopsy bites.

Lung transplant biopsy bites.: In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability.

Study summary

Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician. Exclusion Criteria: * Patients who declined participation or unable to give informed consent.

Primary outcome measure(s)

Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies. — two years
Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
Report the molecular diagnoses of the MMDx-TBB system — two years
Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.

Trial sites (11)

Facility	City	Region	Status
St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT	Phoenix	Arizona	Recruiting
University of Maryland School of Medicine	Baltimore	Maryland	Completed
Division of Pulmonary and Critical Care, Washington University School of Medicine	St Louis	Missouri	Completed
University of Texas at San Antonio	San Antonio	Texas	Completed
The Alfred Hospital, Monash University	Melbourne	Australia	Completed
Department of Thoracic Surgery, Medical University of Vienna	Vienna	Austria	Completed
Alberta Transplant Applied Genomics Centre, University of Alberta	Edmonton	Alberta	Recruiting
Department of Medicine, University of Alberta	Edmonton	Alberta	Recruiting
University Health Network, Toronto General Hospital	Toronto	Ontario	Completed
Charles University/Hospital Motol	Prague	Czechia	Recruiting
Thoracic Surgery Transplant Clinic	Szczecin	Poland	Completed

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02812290 on ClinicalTrials.gov ↗ ← All trials in Canada